510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,569

176,366 records, page 3182 of 3528

510(k) clearances, page 3182 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K823809	Clavical Strap	Danek Medical, Inc.	IQJ	Class I	1983-01-14
K823808	Various Arm Sling	Danek Medical, Inc.	ILI	Class I	1983-01-14
K823806	Direct Creatinine Procedure	Analytical & Research Chemicals, Inc.	CGX	Class II	1983-01-14
K823801	Ames Tda Ethosuximide Test	Miles Laboratories, Inc.	DLF	Class II	1983-01-14
K823794	Control Tm 8	General Diagnostics	GLQ	Class II	1983-01-14
K823793	Abc Brand	Beiersdorf, Inc.			1983-01-14
K823786	Alkaline Phosphatase	Analytical & Research Chemicals, Inc.	CJE	Class II	1983-01-14
K823784	Enzymatic Cholesterol (Colorimetric	Analytical & Research Chemicals, Inc.	CHH	Class I	1983-01-14
K823776	Pi-Pneumo-Intestinal Instrument Set	Surgeons Choice, Inc.	GAG	Class II	1983-01-14
K823775	Bordon Gage Regulator #Bg	Timeter Instrument Corp.	CCN	Class I	1983-01-14
K823772	Amsco Orthographic 2 Table	American Sterilizer Co.	BWN	Class I	1983-01-14
K823760	Prick-Test Needle	Cordis US Corp.	FMK	Class II	1983-01-14
K823752	Extracorporeal Subclavian Catheter Kit	Extracorporeal Medical Specialities, Inc.	FIQ	Class II	1983-01-14
K823750	Cleaning Agent	Shaban Mfg. Co.	CHL	Class II	1983-01-14
K823733	Eiken Kizai Artificial Kidney Blood Cir	Advocacy International, Ltd.	KOC	Class II	1983-01-14
K823716	Cystoflo Urinary Drainage Bag W/antimic	Travenol Laboratories, S.A.	KNX	Class II	1983-01-14
K823695	Cpm Metabolic Monitor	Medicor USA, Ltd.	BZL	Class II	1983-01-14
K823674	High Frequency Epilator Cb-2	R. A. Fischer Co. Corp.	KCW	Class I	1983-01-14
K823562	EMG Modules for Polygraph System	Nihon Kohden America Inc	IKN	Class II	1983-01-14
K823539	Sutter Cpm	Sutter Biomedical, Inc.	BXB	Class I	1983-01-14
K823523	Toxi-Lab Rapid Screen	Marion Laboratories, Inc.	DKJ	Class II	1983-01-14
K823508	Lifeline -Unipolar Lead #487-05	Intermedics, Inc.	DTB	Class III	1983-01-14
K823494	Total Ige-Fast Test	Axonics, Inc.	DGC	Class II	1983-01-14
K823451	Clear Cardioplejia Delivery System	3M Health Care, Sarns	DTR	Class II	1983-01-14
K823438	Handi-Tray	Treace Medical, Inc.	FSM	Class I	1983-01-14
K823361	Switching Unit Electrode Catheters	Webster Laboratories, Inc.	DRF	Class II	1983-01-14
K823284	Stryker Constavac	Stryker Corp.	GCY	Class I	1983-01-14
K823040	Pathology Instrumentation & Accessories	Iris Remote Imaging Systems	IBJ	Class I	1983-01-14
K822979	Cementless Zweymueller Hip Endoprothes	Allo Pro Corp.	JDI	Class II	1983-01-14
K822362	Alta II ECG Recorder	Scole Engineering Co.	DSH	Class II	1983-01-14
K823866	Advance Emit Cad Lidocaine Assay	Syva Co.	KLR	Class II	1983-01-12
K823842	Phadezym Rast Allergen Discs	Pharmacia, Inc.	DGC	Class II	1983-01-12
K823841	Phadebas Rast Allergen Discs	Pharmacia, Inc.	DGC	Class II	1983-01-12
K823838	Infuse-a-Port	Infusaid Corp.	LJT	Class II	1983-01-12
K823826	Capillary Flow Dialyzers	Travenol Laboratories, S.A.	KOC	Class II	1983-01-12
K823791	Lundia 10-5-L Parralle Flow Dialyzer	Gambro, Inc.	KOC	Class II	1983-01-12
K823762	Various-Analyzer Cups	Cordis US Corp.	JJE	Class I	1983-01-12
K823756	Ultra Chem Cresolphthalein Calcium 65082	Em Industries, Inc.	CIC	Class II	1983-01-12
K823751	Sopheia Thyroxine Eia Kit	Siemens Healthcare Diagnostics Inc.	KLI	Class II	1983-01-12
K823746	Advance Sys. Emit-AED Antiepileptic Drug	Syva Co.	DIF	Class I	1983-01-12
K823737	Made-to-Measure Surgical Elastic Support	Gotfried Medical, Inc.	DWL	Class II	1983-01-12
K823689	3M Scotchplate 51148 Small Conductive	3M Company	GEI	Class II	1983-01-12
K823670	E.s. Pencil	Surgicare Scientific Laboratory, Inc.	GEI	Class II	1983-01-12
K823568	Poly-Tone Denture Base Resin	General Dental Products, Inc.	EBI	Class II	1983-01-12
K823563	EEG & Respiration Modules Polygraph	Nihon Kohden America Inc	BZQ	Class II	1983-01-12
K823333	Model 400 & 700 Temp. Sensor Adapters	Mon-A-Therm, Inc.	FLL	Class II	1983-01-12
K823264	Thyroxine Analysis Products/radio-Free	BD Becton Dickinson Vacutainer Systems Preanalytic	CEC	Class II	1983-01-12
K823221	Acca-Temp Skin Temp. Vinyl Disc	T. G. & E. Medical	KPD	Class II	1983-01-12
K823214	Dosimetric Release Program - Admin. Set	Cutter Laboratories, Inc.	FPA	Class II	1983-01-12
K823076	Satoban First Aid Tape	Food and Drug Service, Inc.	KGX	Class I	1983-01-12